Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DANA DIABECARE

K-Number: K001604 · 2000-08-14

ApplicantSooil Development Co., Ltd.
Decision Date2000-08-14
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DANA DIABECARE is the device name listed in this FDA 510(k) record. The listed applicant is Sooil Development Co., Ltd.. It received FDA 510(k) clearance on 2000-08-14 under 510(k) number K001604. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANA DIABECARE?

DANA DIABECARE is a medical device that received FDA 510(k) clearance on 2000-08-14. The listed applicant is Sooil Development Co., Ltd.. The 510(k) number is K001604.

When did DANA DIABECARE receive FDA 510(k) clearance?

DANA DIABECARE received FDA 510(k) clearance on 2000-08-14, under 510(k) number K001604.

Who is the listed applicant for DANA DIABECARE?

The FDA 510(k) record lists Sooil Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DANA DIABECARE?

The FDA product code for DANA DIABECARE is LZG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sooil Development Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071418DANA 3CC SYRINGE INSULIN RESERVOIRK063126DANA DIABECARE IISK022317DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS

Related Devices (Code: LZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑